NCT03458520

Brief Summary

The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2018Dec 2026

Study Start

First participant enrolled

February 1, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

8.9 years

First QC Date

March 2, 2018

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of tumors

    Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.

    up to 12 months

Secondary Outcomes (1)

  • Metabolic activity of tumors

    up to 12 months

Study Arms (1)

Image Registry

patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging)

Diagnostic Test: PET/MR imagingDiagnostic Test: MR imagingDiagnostic Test: PET/CT imaging

Interventions

PET/MR imagingDIAGNOSTIC_TEST

undergo PET/MR imaging

Also known as: positron emission tomography
Image Registry
MR imagingDIAGNOSTIC_TEST

Undergo MR imaging

Also known as: magnetic resonance imaging
Image Registry
PET/CT imagingDIAGNOSTIC_TEST

Undergo PET/CT imaging

Also known as: computed tomography
Image Registry

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and young adult (\<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor

You may qualify if:

  • Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
  • We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
  • Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.

You may not qualify if:

  • Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level \> 200 mg/dl.
  • Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
  • Patient has a CNS primary tumor.
  • Pregnant women and fetuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

LymphomaOsteosarcoma

Interventions

Positron-Emission TomographyMagnetic Resonance ImagingTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcoma

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeRadiographic Image EnhancementRadiographyTomography, X-Ray

Study Officials

  • Heike Daldrup-Link, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

February 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations